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OpenTrials
Completed

NCT Number: NCT01425346

ClearPath DS-120 Clinical Study Protocol

The goal of this study is to measure lens fluorescence in normal subjects at various chronological ages that could serves as a guide to clinicians in determining changes in eye health. A measure of lens fluorescence can be used by clinicians as an indication of degenerative changes occurring in the lens of the eye.

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Key information

Conditions

Ophthalmic, Healthy Eyes

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Diego Optometry Practice

San Diego, California, 92122, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons between the ages of twenty-one (21) and seventy (70). Best efforts shall be made to include as many patients as possible between the ages of thirty-five (35) and sixty (60).
  • Subject must be able to read or understand and give informed consent.
  • Pass the medical health history and comprehensive ophthalmic examination (which is determined by the investigator if the test subject has a normal ophthalmic examination and is in overall good health). Ophthalmic examination includes a clinical evaluation of the subject's eyes and a complete manifest refraction producing a best aided visual acuity of <20/40.

Exclusion criteria

  • Subject has had the crystalline lens removed from the study eye or has had the crystalline lens removed and replaced with an intraocular lens (IOL) implant in the left eye.
  • Subject has been clinically diagnosed with cataracts in the study eye.
  • Subject has had a fluorescence angiogram within the last six months.
  • Subject has undergone a treatment using photodynamic drugs within the last year.
  • Subject has Type I or II diabetes or is not deemed healthy from Demographic and Health Questionnaire or the comprehensive eye exam.
  • Subject was fit with contact lens within the last 30 days.
  • Subject has ocular surface (dry eye) disease.
  • Subject is unable to cooperate with or understand clinical instructions.
  • Subject is unable to complete test sequence

Treatment and study plan

Primary outcomes

  1. Lens fluorescence

    Time frame: Day 1

    evaluate the ability of the ClearPath DS-120 instrument to measure the fluorescence and scattering responses of the human crystalline lens in a normal subject population with healthy eyes (as determined by standard comprehensive ophthalmic examination).

Sponsors and collaborators

Lead sponsor

Freedom Meditech

Industry

Registry information

Official study title

Freedom Meditech ClearPath DS-120 Clinical Study Protocol FM2-002-CTP

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 30, 2011
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.